Diclegis Side Effects: Drowsiness & Sleepiness

Diclegis Side Effects. Last April this year, the U.S. Food and Drug Administration (FDA) approved Diclegis for the treatment of nausea and vomiting among pregnant women. The drug has been proven to be effective in treating said conditions and is, reportedly, the only drug approved by the FDA to treat NVP (nausea and vomiting of pregnancy) in women who do not respond to conservative management. But does Diclegis have side effects that we should be aware of? [Note: Diclegis is marketed as Diclectin in Canada.]

Well, according to the FDA media release, the most common side effect of this drug is drowsiness or sleepiness which can be severe. Which is why it is recommended that you should avoid using Diclegis if you have to do something which requires you to be mentally alert.

diclegis side effects

What do health practitioners say about this newly-approved drug? Dr. Jennifer Ashton, ABC News senior medical contributor and a practicing ob-gyn, gave it a thumbs up. She says it is safe as evidenced by its Pregnancy Category A status (via ABC News):

Both pregnant women and their health care providers are always cautious when using any drug during pregnancy because of the potential harm to the fetus. There are no 100 percent guarantees, but a rating of Pregnancy Category A is the safest level we have in our therapeutic arsenal.

Dr. Keith Eddelman, director of obstetrics at the Mount Sinai Medical Center in New York City, adds:

It is not a controversial drug, and the data is very convincing. … This new FDA medication is a great option for pregnant women suffering from morning sickness.

Finally, here’s what an FDA director (Dr. Hylton V. Joffe, director of the Division of Reproductive and Urologic Productssays) about Diclegis:

Many women experience nausea and vomiting during pregnancy, and sometimes these symptoms are not adequately managed through recommended changes in diet and lifestyle. Diclegis is now the only FDA-approved treatment for nausea and vomiting due to pregnancy, providing a therapeutic option for pregnant women seeking relief from these symptoms.

Still it is worth noting that drugs.com has listed several adverse events which have been identified during the post approval use of the combination of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride (i.e., the main components of Diclegis). Said adverse events are as follows:

  • Cardiac disorders: dyspnea, palpitation, tachycardia
  • Ear and labyrinth disorders: vertigo
  • Eye disorders: vision blurred, visual disturbances
  • Gastrointestinal disorders: abdominal distension, abdominal pain, constipation, diarrhea
  • General disorders and administration site conditions: chest discomfort, fatigue, irritability, malaise
  • Immune system disorders: hypersensitivity
  • Nervous system disorders: dizziness, headache, migraines, paresthesia, psychomotor hyperactivity
  • Psychiatric disorders: anxiety, disorientation, insomnia, nightmares
  • Renal and urinary disorders: dysuria, urinary retention
  • Skin and subcutaneous tissue disorders: hyperhidrosis, pruritus, rash, rash maculo-papular

It is important to note that because of the nature of the info data (i.e., coming from an uncertain population size and voluntarily reported), it is not correct to assume that the abovementioned adverse health reactions are causally related to exposure to Diclegis.